Senior Process Engineer, Cryopreservation CAR-T

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at

Job Function
Supply Chain Manufacturing

Job Sub Function
Manufacturing Pharmaceutical Process Operations

Job Category
Professional

All Job Posting Locations:
Beerse, Antwerp, Belgium

Job Description
Job Description
At Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We collaborate with the world for the health of everyone in it.

We are seeking a highly motivated and skilled
Cryopreservation Process & Excellence Engineer
to join our CAR-T Cryopreservation team in Beerse. You will be playing a crucial role in bringing life-saving treatments to oncology patients in need. Autologous CAR-T therapies have shown remarkable results and have the potential to transform the treatment of cancer. By supporting the Cryopreservation Facility in Beerse (cCPC Beerse), you will be contributing to the success of our CAR-T therapies and directly impacting the lives of our patients.

In this role, you will be responsible for the design, maintenance and continuous improvement of the cryopreservation production system in cCPC Beerse. Moreover, you will be leading strategic projects to support a scale-up towards the target of >5000 patients per year, and to enable manufacturing for pipeline CAR-T products. Ensuring the highest level of quality and compliance with Tissue & Cell Directives is an integral part of the job. You will work in a team-based, international environment allowing a broad scope and plenty of opportunities for personal and career development.

This is a unique opportunity to work with a top-class team dedicated to developing and delivering life-saving therapies to patients. If you have a passion for innovative science, a can-do mentality, and a commitment to lab excellence, then we want to hear from you.

Responsibilities

• Responsible for the design, maintenance and continuous improvement of the cryopreservation production system in cCPC Beerse. This in close alignment with the Global Cell Collection team and in collaboration with the Supervisors CAR-T Cryopreservation

• Ensure the cryopreservation production system is in compliance with legislation, following the appropriate safety measures and quality standards

• Develop, review & approve operational instructions, procedures and logbooks

• Provide operational input to, review & approve documentation related to system design and qualification

• Ensure that the cryopreservation production system is and remains in sync with other departments such as (but not limited to) DC Beerse, Operations CAR-T Ghent (Obelisc and Tech Lane), and Vein-to-Vein

• Lead and assess complex changes related to the cryopreservation production system

• Operational assessment for changes in the cryopreservation production system or with potential impact on it. Ensure that changes are fit for execution and take into account safety, quality & compliance standards

• Own and support risk management processes with impact on Operations

• Lead strategic projects for cCPC Beerse, including (but not limited to):

• Enable manufacturing for pipeline CAR-T products

• Scale-up facility & processes towards a volume of >5000 patients per year

• Automation for cryoformulation process

• Contribute to root cause investigations when required, and act as spokesperson for designated areas during health care inspections

• Daily participation during TIER meetings & frequent presence on the manufacturing floor to ensure involvement in day-to-day operations
• Participation in Change Control/Technical Board, Quality Improvement Plan (QIP) meetings, etc. with a focus on continuous improvement of the cryopreservation production system design and operational execution
• Develop & maintain in depth understanding of the manufacturing processes, the regulatory framework, operational procedures and the manufacturing environment (Facilities, Utilities, Equipment, Systems, Processes)
• Design and run metrics to regularly monitor facility performance
• Act as back-up Facility Lead Cryopreservation during his absence

Qualifications

• Master's degree in a scientific or technical field related to cell processing (Engineering, Bioscience Engineering, Pharmacy, Biochemistry, …)
• A minimum of 3 years of professional experience in a pharma environment is required
• Clear understanding of GMP is required. Knowledge of GTP is preferred
• Understanding of Prevention related regulations (EH&S) and guidelines
• Knowledge of key internal and international policies and procedures
• Project management skills and the ability to interface cross-functionally with clinical, supply chain and manufacturing personnel is required
• Some years of laboratory experience is preferred
• Strong attention to detail and ability to work independently
• Ability to summarize and present results, and experience with team-based collaborations
• Ability to manage an ambiguous environment and work with a sense of urgency
• Excellent communication and interpersonal skills
• Fluent in Dutch and English (spoken as well as written)
• Eligible to work in Belgium